CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine +1 morebiological
Likely dose
ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803569
NCT00803569Phase 1Completed
CompareCT.gov

Phase I Study of ALVAC(2)-NY-ESO-1(M)/TRICOM (VCP2292) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen

Ludwig Institute for Cancer Research·interventional·Posted Dec 5, 2008·Updated Oct 4, 2023

In Brief

A Phase 1 clinical trial evaluating ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine and Sargramostim for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary peritoneal cavity cancers who had completed standard therapy for primary or recurrent disease and would have normally entered a period of observation. The primary study objective was to determine the safety and tolerability of study vaccination, with secondary objectives including the determination of clinical and immunological responses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsRoswell Park Cancer Institute, New York University Cancer Institute

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartNov 14, 2008
Primary CompletionJan 24, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago

Interventions

ALVAC(2)-NY-ESO-1(M)/TRICOM vaccinebiological

The vaccine comprises the modified canary pox vector, ALVAC(2), inserted with the following genes: NYESO-1(M), TRICOM (LFA-3, ICAM-1, B7.1), vvE3L, vvK3L. The vaccine is administered at a dose of 0.5 mL SC.

Sargramostimbiological

The GM-CSF sargramostim is administered at a dose of 100 μg SC.